# K143573: Audit MicroControls Linearity FD Tumor Markers II

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jan 16, 2015 after 30 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910440 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082717: Audit Microcv Tumor Markers Linearity Set, Model K719M-5, Aalto Scientific, Ltd. (2008) Summary page 4.

## Indications for use
The Linearity FD Tumor Markers II is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)/(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3). The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K143573
Methodology: https://510kreport.com/methodology